Gene D. Arcy
FDA investigator · also recorded as Se Gene Arcy
Appears on 16 documents from 2003 to 2025, most often at sites in California. Most often cites production record review (21 CFR 211.192).
- 16
- Documents on file
- 4.8
- Observations per 483
- 2003
- First seen
- 2025
- Most recent
What they cite most
From 75 observations- 21 CFR 211.192Production record review10
- 21 CFR 211.100Written procedures; deviations7
- 21 CFR 211.110Sampling and testing of in-process materials and drug products7
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.42Design and construction features5
Activity by year
2003: 1, 2016: 1, 2017: 2, 2018: 1, 2019: 2, 2020: 1, 2021: 1, 2022: 1, 2023: 3, 2024: 2, 2025: 1
Where
California 4 · North Carolina 3 · Michigan 2 · Australia 1 · Belgium 1 · Massachusetts 1
Often inspects with
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Inspection history
16 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-09-18 | 483 Baxalta US IncSep 18, 2025 · Thou sand Oak s, California | Thou sand Oak s, California | 2 | |
| 2024-05-28 | 483 FinVector OyMay 28, 2024 | — | 5 | |
| 2024-03-15 | 483 MedImmune UK LimitedMar 15, 2024 · Liverpool, United Kingdom | Liverpool, United Kingdom | 4 | |
| 2023-10-17 | 483 Biogen U.S. CorporationOct 17, 2023 · Morrisville, North Carolina | Morrisville, North Carolina | 5 | |
| 2023-09-19 | 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCSep 19, 2023 · Andover, Massachusetts | Andover, Massachusetts | 3 | |
| 2023-06-16 | 483 Pharmacia & Upjohn Company LLCJun 16, 2023 · Kalamazoo, Michigan | Kalamazoo, Michigan | 7 | |
| 2022-05-06 | 483 Grifols Therapeutics LLCMay 6, 2022 · Clayton, North Carolina | Clayton, North Carolina | 2 |
About this profile
What does Gene D. Arcy inspect?
Gene D. Arcy appears on 16 documents on file covering 14 sites, most often in California.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.100 and 21 CFR 211.110.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Gene D. Arcy is dated Sep 18, 2025.